Gelatin is used in various pharmaceutical and nutraceutical products, including soft gelatin capsules and hard gelatin capsule shells as well as many different food applications. Soft gelatin capsules are typically used to encapsulate a solution or dispersion of, for example, a nutritional or pharmaceutical active agent in a liquid carrier, and have many advantages over other dosage forms, permitting accurate delivery of a unit dose in an easy-to-swallow, transportable, essentially tasteless form. However, gelatin has many drawbacks, including the cost and continuity of a safe supply.
Conventional fillers have been added to gelatin free films and capsules to increase the solid loading in order to improve the quality of throughput in the manufacturing process. However, the addition of conventional fillers results in translucent and even opaque films and capsules. In the case of traditional fillers with a high refractive index, such as calcium carbonate and titanium oxide, there is a negative effect on film transparency even at low concentrations. Most of these fillers have a whitening effect. Other traditional fillers produce unacceptable melt viscosities or undesirable film quality.
There continues to be a need in the art for substantially gelatin-free composition for pharmaceutical, nutraceutical and food application systems that increases the total solids loading while maintaining transparency. The present invention addresses this need.